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Modernizing Perinatal Syphilis Testing

RecruitingNAAges any - 45 YearsAllThe University of Texas Health Science Center, Ho…
NCT06082453 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth * Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis Exclusion Criteria: * Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive) * Planning to move outside of study prior to ND testing
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What it tests

  • Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
  • Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
  • Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
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Where

9 sites
University of Southern California
Los Angeles, United States
University of California, Los Angeles
Los Angeles, United States
Johns Hopkins University
Baltimore, United States
Kennedy Krieger Institute
Baltimore, United States
Nationwide Children's Hospital
Columbus, United States
Baylor College of Medicine
Houston, United States
Texas Children's Hospital
Houston, United States
The University of Texas Health Science Center at Houston
Houston, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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